CHC - PV Literature Surveillance Lead - All Gender in Bucuresti

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world. We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.ABOUT THE JOBOur TeamCHC PV Literature Surveillance lead is a Leadership member of the CHC PV Operations team and reports to the CHC PV Operations Head. This position includes responsibilities for the oversight of global Literature Screening in support of ICSR, Periodic Reporting and Signal/Risk Management. This position is responsible for providing the strategic vision, planning and oversight on publishing of all CHC PV regulatory documents. This position maintains oversight and responsibility for global publishing vendors.Key results/accountabilitiesResponsible for the medical evaluation of complex scientific and medical literature publications encompassing all types of publications including study publications for clinical studies - for all CHC productsThese publications are identified by approved screening criteria from various sources including numerous external databases and from license partnersThe medical evaluation of the publications ensures high medical quality and compliance with health authority requirements regarding literature review and single case handlingSupervise and support the work of vendor team performing PV literature surveillance activities according to appropriate regulations and agreed processes as listed belowPerform end-to-end literature review and make the determination if the article is relevant for signal detection and/or inclusion in periodic reports and/or contains an ICSR (detection and narrative writing)maintaining and documenting up-to-date product knowledge to aid in literature reviewcreating and maintaining literature search strategies (in house or in collaboration with vendors)Identifies critical case reports and other medical and scientific publications that require immediate attention of the Global Safety officersRequests follow-up information from authors, when necessary in regard to further handling of the received information within pharmacovigilance i.e. risk management Serves as medical mentor for Literature Reviewers of Contract Research Organization (CRO) for the accuracy of literature review result, case selection and correct documentation and provides expert guidance for the accurate medical assessment of literature publications to PV Case ProcessorsEnsures compliance with QD/SOPs and health authority regulations by executing QC steps regarding the Literature review and processPerforms ongoing quality checks of CRO literature review and literature case entry and provides feedback also for training purposes of the colleagues at the CRODeploy processes related to the EMA Medical Literature Monitoring to avoid sending duplicate cases to the EMAContinued interaction with all PV Single Case Processing, PV Risk Management, outsourced CRO and Product Information Group to ensure high quality of literature reviewResponsible for continuous process improvement activities related to area of responsibilityResponsible to maintain good documentation practice and be the Point of Contact in case of inspection/auditKey working relationshipsThis role will be the key contact point for countries and regions for all topics related to PV Literature surveillanceThis position requires multiple interfaces with partners and customers within and outside of the Company this includes Regulatory, TA team and PSR teamWork closely with CHC PSR team membersIt requires experience in managing complex issues in a global environmentABOUT YOUEducationPharmD or Phd or Equivalent with 8 years of Pharmacovigilance experience with at least 4 years in PV Literature Surveillance experienceRequired knowledge and/or experienceKnowledge of pharmacovigilance processes including global and local regulatory requirements and rulesMust have knowledge of the EMA Medical Literature Monitoring (MLM)regulations, ICH principles of SAE/AE reporting along with an understanding of global regulatory rules and regulations and knowledge of safety policies and procedures in the major countriesMust have a good understanding of AE coding conventions (MedDRA)Ability to write/update/contribute to quality documents/job aids/WINs and developing training material to perform training to PVAbility to manage and lead transversal meetings and small to moderate size groups and take appropriate decisionsStrong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environmentLanguage skillsFluent spoken and written EnglishSoft skillsLeadership, Teamwork and Management skillsGood interpersonal and negotiator skillsStrong decision-making skillsPlay to Win Behaviours StretchTake actionAct for patients & customers Think Sanofi first Pursue Progress. Discover Extraordinary.#LI-EUR#LI-HYBRIDAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.